The ORA Quality Manual contains the required policy elements to structure the Office of Regulatory Affairs (ORA) Quality Management System (QMS). The anticipated audience for this manual includes those in the public, regulated industry, counterpart agencies, and FDA who wish to understand the ORA QMS. Use of this manual presumes some understanding of quality system principles and standards.
Download Link:
http://rapidshare.com/files/97417420/Qty.manual07.zip
Download Link:
http://rapidshare.com/files/97417420/Qty.manual07.zip
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